Extrinsic and Intrinsic Factors in Atopic Dermatitis Upon Systemic Immune Modulation

NCT05098821 | Recruiting

• 1 other identifier: PRI-ADD
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Pattern recognition of immune cells (PRI) is an efficient method to screen patients to allow a more personalized therapy. The main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. This allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.

Conditions

Atopic Dermatitis

Keywords

dupilumab; pattern recognition; immune cells

Outcome Measures

Primary Outcomes (1)

• Comparison of T-cell inflammatory markers

  Identification of at least one pattern recognition profile showing a strong association with responder status to dupilumab therapy

  1 year

Secondary Outcomes (3)

• Different T-cell pattern with dupilumab therapy

  1.5 years

• Assign recognition patterns to clinical symptoms

  3 months

• Connection of molecular profile and phenotype

  3 months

Study Arms (1)

Dupilumab treated Patients

Patients with atopic dermatitis with indication for dupilumab treatments will be observed

Other: not applicable, observational study

Interventions

not applicable, observational study OTHER

Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study

Dupilumab treated Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with moderate to severe atopic dermatitis presenting in the clinic of Dermatology, Charité - Universitätsmedizin Berlin, Germany

You may qualify if:

• Age 18 and above
• Diagnosis of atopic dermatitis for ≥1 year
• Inadequate response to treatment with topical medications
• Confirmed dupilumab treatment

You may not qualify if:

• Age below 18
• Known or suspected allergy or reaction to any component of the dupilumab formulation
• Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of the severity of AD
• Severe conjunctivitis or blepharitis

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Sanofi: collaborator
• LEO Pharma: collaborator

Study Sites (1)

Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Observation

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Margitta Worm

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 28, 2021
• Study Start: October 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

DE (1)